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Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia

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ClinicalTrials.gov Identifier: NCT03703271
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Sun Yat-sen University
Huazhong University of Science and Technology
Qilu Hospital of Shandong University
Information provided by (Responsible Party):
Women's Hospital School Of Medicine Zhejiang University

Brief Summary:
Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Neoplasia Drug: Methotrexate Procedure: hysteroscopic repeat curettage Phase 3

Detailed Description:

Gestational trophoblastic neoplasia (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which are secondary to hydatidiform mole, and 95% of GTN patients present low-risk gestational trophoblastic neoplasia(LR-GTN).In the 1960s and 1970s, with the in-depth study of the disease, it was found that the malignant tumor was highly sensitive to chemotherapy and had ideal tumor marker HCG to guide the treatment and follow-up. Therefore, GTN was the best malignant tumor with the overall cure rate of LR-GTN nearly 100%.MTX single-drug multi-course chemotherapy is the classic treatment of LR-GTN recommended by FIGO, but most patients can develop gastrointestinal, blood and liver toxicity during chemotherapy. In addition, the longer treatment cycle also brings a lot of discomfort to patients.

In recent years, some scholars proposed that the selection of treatment regimen of LR-GTN secondary to hydatidiform pregnancy should consider the toxic and side effects of chemotherapy, the maintenance of patients' physiological functions and quality of life.Retrospective studies abroad have shown that LR-GTN delayed chemotherapy for hydatidiform mole pregnancy only started chemotherapy for LR-GTN at a certain stage of progression, and the results did not change the prognosis of LR-GTN but reduced the rate of chemotherapy.In addition, for some patients with ultra-low risk of LR-GTN in hydatidiform pregnancy undergoing hysteroscopic repeat curettage , the rate of chemotherapy can be reduced, the related costs can be reduced and the quality of life of patients can be improved.

In this prospective, multicenter, randomized, controlled clinical study, with the routine use of a gleam of MTX single drug treatment scheme for comparison, comparing uterine cavity again emptying delay chemotherapy guided by parallel hysteroscopy surgery clinical curative effect and adverse reaction, which discuss after hydatidiform mole ultra-low dangerous GTN patients with uterine cavity emptying again guided by hysteroscopy surgery as a line of ultra low dangerous GTN patients after hydatidiform mole security and feasibility of the treatmen


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: chemotherapy
Methotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle
Drug: Methotrexate
single-agent 5-day methotrexate, two weeks a cycle
Other Name: Methotrexate chemotherapy

Experimental: study group
hysteroscopic repeat curettage
Procedure: hysteroscopic repeat curettage
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
Other Name: complete curettage




Primary Outcome Measures :
  1. complete remission rate in firstline treatment [ Time Frame: 2 years ]
    The investigators may calculate the rate of complete response at the preliminary end point of the trail


Secondary Outcome Measures :
  1. Complications of hysteroscopic repeat curettage surgery [ Time Frame: 2 years ]
    The investigators may record the complications of hysteroscopic repeat curettage surgery

  2. Severity of adverse events as assessed by the WHO [ Time Frame: 2 years ]
    The investigators may record the adverse events of chemotherapy as assessed by the WHO

  3. Overall Survival Rate (OR) [ Time Frame: 2 years ]
    Overall Survival Rate of the two group patients

  4. Ovarian functional evaluation [ Time Frame: 2 years ]
    The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months.

  5. The pregnancy rate [ Time Frame: 2 years ]
    To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail

  6. Menstrual cycle resuming rate [ Time Frame: 2 years ]
    The investigators record the time of menstrual cycle resuming after chemotherapy



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • low-risk postmolar gestational trophoblastic neoplasia (GTN)
  • World Health Organization(WHO) risk score≤4
  • Age≤60 years; female, Chinese women
  • Initial treatment
  • Performance status: Karnofsky score≥60
  • Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal
  • Provide written informed consent.

Exclusion Criteria:

  • Patients with unconfirmed diagnosis of GTN
  • Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • WHO risk score ≥5分
  • The diameter of a single metastatic lesion in the lung was ≥2cm
  • The number of lung CT metastases was≥ 5
  • With severe or uncontrolled internal disease, unable to receive chemotherapy
  • Concurrently participating in other clinical trials
  • Unable or unwilling to sign informed consents
  • Unable or unwilling to abide by protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703271


Locations
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China, Zhejiang
Weiguo Lv Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Weiguo Lv, Doctor    13588193832    13588193832@163.com   
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
Sun Yat-sen University
Huazhong University of Science and Technology
Qilu Hospital of Shandong University

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Responsible Party: Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT03703271     History of Changes
Other Study ID Numbers: ZJHGTN1212
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's Hospital School Of Medicine Zhejiang University:
postmolar
Gestational Trophoblastic Neoplasia
hysteroscopic
repeat curettage
methotrexate
Additional relevant MeSH terms:
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Gestational Trophoblastic Disease
Neoplasms
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors